Silvio E Inzucchi1, Guillermo Umpierrez2, Andres DiGenio3, Rong Zhou4, Boris Kovatchev5. 1. Yale School of Medicine, New Haven, CT, USA. Electronic address: silvio.inzucchi@yale.edu. 2. Emory University School of Medicine, Atlanta, GA, USA. 3. Isis Pharmaceuticals, Inc., Carlsbad, CA. 4. Medpace, Inc., Cincinnati, OH, USA. 5. University of Virginia Health System, Charlottesville, VA, USA.
Abstract
AIM: Despite links to clinical outcomes in patients with type 2 diabetes mellitus (T2DM), the clinical utility of glycaemic variability (GV) measures is unknown. We evaluated the correlation between baseline GV, and glycated haemoglobin (HbA1c) attainment and hypoglycaemic events during treatment intensification in a large group of patients. METHODS: Patient-level data from six 24-week clinical trials of T2DM patients undergoing treatment intensification with basal insulin or comparators (N=1699) were pooled. Baseline GV measures included standard deviation (SD), mean amplitude of glycaemic excursions (MAGE), mean absolute glucose (MAG), coefficient of variation (CV), high blood glucose index (HBGI), and low blood glucose index (LBGI) were correlated with HbA1c change and hypoglycaemic events. RESULTS: All mean GV measures, excluding CV which worsened, improved significantly from baseline to Week 24, with the largest proportional reduction obtained for HBGI (-65.5%). When assessed as mean individual percentage changes only HBGI improved significantly. Baseline GV correlated positively with Week 24 HbA1c for SD, MAGE, and HBGI. Baseline HBGI and CV correlated negatively and positively, respectively, with Week 24 HbA1c change. Correlations also existed between most baseline GV measures and age, body mass index, Week 24 fasting plasma glucose, Week 24 postprandial plasma glucose, and hypoglycaemic events; statistical significance depended on the specific measure. CONCLUSIONS: Pre-treatment GV is associated with glycaemic outcomes in T2DM patients undergoing treatment intensification over 24 weeks. HBGI might be the most robust predictor, warranting validation in dedicated prospective studies or randomized trials to assess the predictive value of measuring GV.
RCT Entities:
AIM: Despite links to clinical outcomes in patients with type 2 diabetes mellitus (T2DM), the clinical utility of glycaemic variability (GV) measures is unknown. We evaluated the correlation between baseline GV, and glycated haemoglobin (HbA1c) attainment and hypoglycaemic events during treatment intensification in a large group of patients. METHODS:Patient-level data from six 24-week clinical trials of T2DM patients undergoing treatment intensification with basal insulin or comparators (N=1699) were pooled. Baseline GV measures included standard deviation (SD), mean amplitude of glycaemic excursions (MAGE), mean absolute glucose (MAG), coefficient of variation (CV), high blood glucose index (HBGI), and low blood glucose index (LBGI) were correlated with HbA1c change and hypoglycaemic events. RESULTS: All mean GV measures, excluding CV which worsened, improved significantly from baseline to Week 24, with the largest proportional reduction obtained for HBGI (-65.5%). When assessed as mean individual percentage changes only HBGI improved significantly. Baseline GV correlated positively with Week 24 HbA1c for SD, MAGE, and HBGI. Baseline HBGI and CV correlated negatively and positively, respectively, with Week 24 HbA1c change. Correlations also existed between most baseline GV measures and age, body mass index, Week 24 fasting plasma glucose, Week 24 postprandial plasma glucose, and hypoglycaemic events; statistical significance depended on the specific measure. CONCLUSIONS: Pre-treatment GV is associated with glycaemic outcomes in T2DM patients undergoing treatment intensification over 24 weeks. HBGI might be the most robust predictor, warranting validation in dedicated prospective studies or randomized trials to assess the predictive value of measuring GV.
Authors: Chirag J Jivanji; Varsha M Asrani; Sayali A Pendharkar; Melody G Bevan; Nicola A Gillies; Danielle H E Soo; Ruma G Singh; Maxim S Petrov Journal: Dig Dis Sci Date: 2017-03-14 Impact factor: 3.199
Authors: María Paula Russo; Santiago Nicolas Marquez Fosser; Cristina María Elizondo; Diego Hernán Giunta; Nora Angélica Fuentes; María Florencia Grande-Ratti Journal: Rev Diabet Stud Date: 2021-11-01
Authors: Da Young Lee; Kyungdo Han; Sanghyun Park; Ji Hee Yu; Ji A Seo; Nam Hoon Kim; Hye Jin Yoo; Sin Gon Kim; Kyung Mook Choi; Sei Hyun Baik; Yong Gyu Park; Nan Hee Kim Journal: Cardiovasc Diabetol Date: 2020-09-22 Impact factor: 9.951
Authors: Da Young Lee; Jaeyoung Kim; Sanghyun Park; So Young Park; Ji Hee Yu; Ji A Seo; Nam Hoon Kim; Hye Jin Yoo; Sin Gon Kim; Kyung Mook Choi; Sei Hyun Baik; Kyungdo Han; Nan Hee Kim Journal: J Clin Med Date: 2021-12-18 Impact factor: 4.241